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Author: Duff William Ramus Waring Publisher: University of Toronto Press ISBN: 0802086438 Category : Medical Languages : en Pages : 281
Book Description
When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.
Author: Duff William Ramus Waring Publisher: University of Toronto Press ISBN: 0802086438 Category : Medical Languages : en Pages : 281
Book Description
When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.
Author: Hazel Biggs Publisher: Routledge ISBN: 1135309272 Category : Law Languages : en Pages : 233
Book Description
The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject. Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.
Author: Aurora Plomer Publisher: Routledge ISBN: 1135338329 Category : Law Languages : en Pages : 335
Book Description
The growing globalization of medical research and the application of new biotechnologies in morally contested areas has forced a revision of international ethical guidelines. This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and changes in form and content of international instruments regulating the conduct of biomedical research. The approach adopted is comparative and includes an evaluation of human rights and UK and US law on embryonic stem cell research, the HIV/AIDS trials in the developing world, the Alder Hey Inquiry and the human radiation and nerve gas experiments on human subjects in the US and the UK. This is the first book to analyze some of the major issues in biomedical research today from an international, comparative human rights perspective.
Author: James M. Humber Publisher: Springer Science & Business Media ISBN: 1461565618 Category : Philosophy Languages : en Pages : 645
Book Description
In the past few years, an increasing number of colleges and universities have added courses in biomedical ethics to their curricula. To some extent, these additions serve to satisfy student demands for "relevance. " But it is also true that such changes reflect a deepening desire on the part of the academic community to deal effectively with a host of problems which must be solved if we are to have a health-care delivery system which is efficient, humane, and just. To a large degree, these problems are the unique result of both rapidly changing moral values and dramatic advances in biomedical technology. The past decade has witnessed sudden and conspicuous controversy over the morality and legality of new practices relating to abortion, therapy for the mentally ill, experimentation using human subjects, forms of genetic interven tion, and euthanasia. Malpractice suits abound, and astronomical fees for malpractice insurance threaten the very possibility of medical and health-care practice. Without the backing of a clear moral consensus, the law is frequently forced into resolving these conflicts only to see the moral issues involved still hotly debated and the validity of the existing law further questioned. Take abortion, for example. Rather than settling the legal issue, the Supreme Court's original abortion decision in Roe v. Wade (1973), seems only to have spurred further legal debate. And of course, whether or not abortion is a mo rally ac ceptable procedure is still the subject of heated dispute.
Author: Remigius N. Nwabueze Publisher: Routledge ISBN: 1317106415 Category : Law Languages : en Pages : 377
Book Description
There has been a rapid increase in the pace and scope of international collaborative research in developing countries in recent years. This study argues that whilst ethical regulation of biomedical research in Africa and other developing countries has attracted global attention, legal liability issues, such as the application of common law rules and the development of legally enforceable regulations, have been neglected. It examines some of the major research scandals in Africa and suggests a new ethical framework against which clinical trials could be conducted. The development of research guidelines in Uganda, Tanzania, Malawi and Nigeria are also examined as well as the role of ethics committees. Providing a detailed analysis of the law of negligence and its application to research ethics committees and their members, common law and constitutional forms of action and potential negligence claims, the book concludes by suggesting new protocols and frameworks, improved regulation and litigation. This book will be a valuable guide for students, researchers, and policy-makers with an interest in medical law and ethics, bioethics, customary law in Africa and regulation in developing countries.
Author: Patricia M. Tereskerz Publisher: John Wiley & Sons ISBN: 1405195673 Category : Medical Languages : en Pages : 295
Book Description
This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.
Author: Jan Schildmann Publisher: Springer Science & Business Media ISBN: 3034803907 Category : Medical Languages : en Pages : 192
Book Description
Medical research involving human subjects has contributed to considerable advancements in our knowledge, and to medical benefits. At the same time the development of new technologies as well as further globalisation of medical research raises questions that require the attention of researchers from a range of disciplines. This book gathers the contributions of researchers from nine different countries, who analyse recent developments in medical research from ethical, historical, legal and socio-cultural perspectives. In addition to reflections on innovations in science such as genetic databases and the concept of “targeted therapy” the book also includes analyses regarding the ethico-legal regulation of new technologies such as human tissue banking or the handling of genetic information potentially relevant for participants in medical research. Country and culture-specific aspects that are relevant to human medical research from a global perspective also play a part. The value of multi- and interdisciplinary analysis that includes the perspectives of scholars from normative and empirical disciplines is a shared premise of each contribution.
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Publisher: ISBN: Category : Bioethics Languages : en Pages : 156
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309676630 Category : Medical Languages : en Pages : 133
Book Description
On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 1-day public workshop in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, but this workshop focused on issues related to the development and use of digital technologies, artificial intelligence, and machine learning in research and clinical practice; issues emerging as nontraditional approaches to health research become more widespread; the role of bioethics in addressing racial and structural inequalities in health; and enhancing the capacity and diversity of the bioethics workforce. This publication summarizes the presentations and discussions from the workshop.
Author: Philip Cheung Publisher: Radcliffe Publishing ISBN: 1846191793 Category : Medical ethics Languages : en Pages : 168
Book Description
It has been claimed by fertility experts that embryos can be screened for 6,000 diseases, thereby the risk of x-linked diseases can be minimised by 'cherry-picking' male embryos that do not carry the abnormal gene. If medical scientists continue to strive for cures, genetic aberrance in human could be a phenomenon of the past...This challenging book explores issues of professional integrity and ethics underpinning medical research. It includes real-life case studies where public trust in medical research has been misplaced and encourages medical professionals to adhere to professional codes of conduct and be informed about their decision making process. It is vital reading for undergraduate and postgraduate students of medicine, law, sociology and social policy, philosophy, health related research and ethics. Practising researchers in medicine and the pharmaceutical industry, and their managers will find it invaluable. The text provides motivation for academics and educators with an interest in research and governance. Healthcare policy makers and shapers, patient rights groups, campaigners and the general media will find the information enlightening. "Over the last four decades, medicine has given hope to many people and saved many lives as a result of the ability of the physicians and surgeons to develop new treatments and innovative surgical techniques. While we can celebrate the success of medical science, we should also critically examine some of these developments against principles and in the light of public opinion." - Philip Cheung.
Author: Duff William Ramus Waring
Author: Duff William Ramus Waring
Author: Hazel Biggs
Author: Aurora Plomer
Author: James M. Humber
Author: Remigius N. Nwabueze
Author: Patricia M. Tereskerz
Author: Jan Schildmann
Author: United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
Author: National Academies of Sciences, Engineering, and Medicine
Author: Philip Cheung